Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
NCT ID: NCT02938390
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2016-10-31
2021-12-31
Brief Summary
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Detailed Description
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Objectives
* Demonstrate that US is an effective means of localizing the IPV intraoperatively.
* Evaluate the frequency of IPV preservation with the use of US.
* Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV.
* Compare observed rate with historical controls.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Ultrasound for localizing intercostal perforating vessels
Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.
Eligibility Criteria
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Inclusion Criteria
* Planned nipple sparing mastectomy
Exclusion Criteria
18 Years
80 Years
FEMALE
No
Sponsors
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Amita Health
OTHER
Responsible Party
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Robert Maganini, MD
Principal Investigator
Principal Investigators
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Robert O Maganini, MD
Role: PRINCIPAL_INVESTIGATOR
Amita Health
Locations
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AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Countries
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References
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Palmer JH, Taylor GI. The vascular territories of the anterior chest wall. Br J Plast Surg. 1986 Jul;39(3):287-99. doi: 10.1016/0007-1226(86)90037-8.
Lemaine V, Hoskin TL, Farley DR, Grant CS, Boughey JC, Torstenson TA, Jacobson SR, Jakub JW, Degnim AC. Introducing the SKIN score: a validated scoring system to assess severity of mastectomy skin flap necrosis. Ann Surg Oncol. 2015 Sep;22(9):2925-32. doi: 10.1245/s10434-015-4409-3. Epub 2015 Jan 30.
Other Identifiers
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Nipple Sparing Study
Identifier Type: -
Identifier Source: org_study_id
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